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Detailed Product Description
Identifications and passes tests:
pH (2%): 5.0 - 7.0
pH (0.5%): 5.0 - 7.5
Specific optical rotation: -78 ~ -90
Related substances: HPLC
Major impurity: NMT 3.0%
Sum of impurities: NMT 17.0%
Phenylalanine: 9% - 12%
Loss on drying: NMT 6.0%
Sulfated ash: NMT 0.75%
Sulfate: 15.5% - 17.5%
Heavy metals: NMT 20ppm
Total viable aerobic count: NMT 10cfu/g
Assay, microbiological (as is): NLT 6500IU/mg
Assay, HPLC (on dried basis):
Sum of polymyxin B1, B2, B3 and B1-l: NLT 80.0%
Polymyxin B3: NMT 6.0%
Polymyxin B1-l: NMT 15.0%
Particle size: NLT 99.0% ≤20μm by volume
NLT 90.0%: ≤15μm by volume
NLT 75.0%: ≤10μm by volume
NLT 35.0%: ≤5μm by volume
Packing: alu. Tin
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